On January 4, 2012, the Food and Drug Administration (FDA) issued an order to manufacturers of transvaginal surgical mesh, requiring the companies to study the device’s risks to women. The mesh patch, which is linked to many serious and painful complications when placed transvaginally, is used to treat female incontinence resulting from pelvic organ prolapse (POP) or stress urinary incontinence (SUI). The FDA has required transvaginal mesh patch makers to research the risks associated with the implant’s treatment of both POP and SUI.
Why wasn’t research conducted before the device was FDA-approved?
Prior to the patch entering the market, as much research as possible was conducted, short of putting the device in a human body. Unlike a drug, which can be tested in human trials, a device cannot be temporarily used to see if it works. This is especially for an implant like transvaginal mesh, which is designed to be permanent.
However, extreme care to monitor women who receive the device could have resulted in much earlier discovery of the implant’s faults. If vaginal mesh manufacturers had put a monitoring system in place to conduct post-market research as patches were implanted, many women may have been spared the terrible complications they have suffered as a result of the implant’s defectiveness. Simply put: the makers of transvaginal mesh did not take accountability for conducting this research, so now the FDA is requiring them to do so.
How does this affect women who have or could receive the implant?
The effect of this additional research could be two-fold. One, if research finds that the risks associated with the transvaginal mesh outweigh the benefits, the device could potentially be removed from the market. This would prevent more women from being harmed by it.
Two, if findings from the studies parallel the current research (which has found that the device is no more effective than traditional treatment and is associated with a high rate of serious complications), current and future cases filed by women against transvaginal mesh manufacturers would be strengthened. Stronger cases are more likely to result in fair compensation for the physical, emotional and financial harm caused to these women.
If you or someone you know has received injuries that may have been caused by a transvaginal mesh implant, contact our office to get help. We offer a confidential consultation during which we can discuss your story and determine if you’re eligible to file a claim for compensation. You deserve compensation for the physical, emotional and financial burdens associated with the dangerous transvaginal mesh device.